Cardiol Therapeutics

Clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease

This Cardiol Therapeutics profile is part of a paid investor education campaign.*

Overview

Cardiol Therapeutics Inc. (TSX:CRDL,OTCQX:CRTPF) is a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease. The Company recently received approval from the U.S. FDA for its Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™, in hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease. CardiolRx™ is an ultra-pure, high concentration cannabidiol oral formulation that is pharmaceutically produced, manufactured under cGMP, and THC-free (<10 ppm). The Company also recently launched Cortalex™, the first THC-free extra-strength formulation of cannabidiol oil available across Canada exclusively online at Medical Cannabis by Shoppers.

Cardiol is planning a Phase II international trial of CardiolRx™ in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary cannabidiol formulations for the treatment of inflammation in the heart that is associated with the development and progression of heart failure. Heart failure is the leading cause of death and hospitalization in North America, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

In collaboration with researchers and opinion leaders at international centers of excellence, including the Houston Methodist DeBakey Heart & Vascular Center and TecSalud del Tecnológico de Monterrey, Mexico, Cardiol is leveraging multidisciplinary expertise in drug delivery, drug formulation, cardiac physiology, and heart failure. The company’s research collaborations provide Cardiol with the optimal platform on which to pursue the commercial development of new therapies for chronic heart failure, a leading cause of death and disability in the western world.

The company’s management team has extensive experience in the research and commercial development of novel therapeutics. Additionally, management is notably invested in the company, holding approximately 20 percent of the outstanding shares.

Cardiol Therapeutics’ Company Highlights

  • Leadership position in cannabidiol-based cardioprotective therapies
  • Lead clinical programs targeting large opportunities in inflammatory heart disease
  • Strong scientific rational for developing cannabidiol (CBD) as an anti-inflammatory agent
  • Proprietary oral formulation entering Phase II/III development – strong innovative pipeline
  • Near-term revenue opportunity to address significant unmet medical markets

Phase II/III COVID-19 Trial

On September 24, 2020, Cardiol announced that the U.S. Food and Drug Administration (FDA) approved the Company’s Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of CardiolRx™, a pharmaceutically produced extra strength cannabidiol formulation, in 422 hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease (CVD). The trial will take place at major centers in the United States, where the prevalence of COVID-19 remains high.

Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64) are at significantly greater risk of developing serious disease from COVID-19 and experience greater morbidity. Moreover, such COVID-19 patients are at significant risk of developing cardiovascular complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during the course of their illness, and which are frequently fatal, with an estimated 30 – 40% of patients who die from COVID-19 doing so from cardiovascular complications. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.

 

Cardiol’s Phase II/III trial has been designed to assess the efficacy, safety, and tolerability of CardiolRx™ in preventing cardiovascular complications in hospitalized patients, with a confirmed diagnosis of COVID-19 within the previous 24 hours, and who have pre-existing CVD and/or significant risk factors for CVD. The composite primary efficacy endpoint will be the difference between the active and placebo groups in the percentage of patients who develop, during the first twenty-eight days following randomization and first dose of study medication, a composite endpoint consisting of one or more of several common outcomes in this patient population, including all-cause mortality, requirement for ICU admission and/or ventilatory support, as well as cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia.

“Receiving approval from the FDA for our IND application to initiate a clinical program in COVID-19 patients represents a major milestone for Cardiol Therapeutics and provides the opportunity to significantly accelerate the commercial development of CardiolRx,” said David Elsley, President and CEO of Cardiol Therapeutics. “The COVID-19 pandemic is providing our Company with a unique opportunity to rapidly study the cardioprotective properties of CardiolRx in patients who have a prior history of, or risk factors for, cardiovascular disease and are most vulnerable to the virus. Subject to study outcomes, our discussions with the FDA indicated that the design and scope of our Phase II/III trial may be used as a registration study in support of a New Drug Application.”

Introducing Cortalex™

Cardiol recently introduced Cortalex™, a THC-free* extra-strength (100 mg/mL concentration) oral cannabidiol (CBD) formulation that is now available across Canada exclusively online at Medical Cannabis by Shoppers, a subsidiary of Shoppers Drug Mart Inc. Cortalex™ is the first pharmaceutically produced CBD specifically formulated for the large number of patients who should not be exposed to THC.

There is a growing demand from paediatricians and family physicians for a CBD formulation that does not contain tetrahydrocannabinol (THC). The Canadian Paediatric Society and The College of Physicians and Surgeons of Ontario recommend that physicians not expose young people under the age of 25 to THC. However, most CBD formulations currently available in Canada contain potentially psychoactive levels of THC and are therefore not appropriate for certain patient populations. This is of particular concern in the case of children and young adults under the age of 25 where THC has been linked to a detrimental impact on brain development. It is also a concern in older individuals, such as those who do not wish to risk intoxication because of the requirements of their occupation, or seniors who might already have chronic diseases that limit coordination or cognitive function and who also wish to avoid intoxication. People over the age of 65 now represent the fastest growing segment of the $500 million medicinal cannabinoid market in Canada.

The commercial introduction of Cortalex™ now makes it possible for patients to receive the potential therapeutic benefits of CBD without the intoxicating effects associated with THC.

Orphan Drug Program for Acute Myocarditis

In June 2019, Cardiol announced its intent to complete an international clinical trial for acute myocarditis, an inflammation of the heart muscle commonly caused by a viral infection of the heart tissue, utilizing its CardiolRx CBD formulation.

The most recent data from the “Global Burden of Disease Study” suggests that the prevalence of myocarditis is approximately 22 per 100,000 population, qualifying the condition as an orphan disease in the U.S. and in Europe. Orphan Drug programs in the U.S. and EU are eligible for accelerated marketing approvals and other incentives, including a prolonged period of market exclusivity.

“The U.S. orphan drug program was successfully utilized to accelerate the first FDA approval of CBD for the treatment of rare forms of pediatric epilepsy and significant shareholder value was created in the process,” stated Cardiol President and CEO David Elsley. “Given the mortality and significant morbidity risk associated with acute myocarditis, we believe there is a similar opportunity in pursuing an expedited development program of our CardiolRx pharmaceutical CBD formulation for this serious orphan disease which has no accepted standard of care.”

Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Symptoms include chest pain, fatigue, shortness of breath, and arrhythmias. Because of the progressive damage to heart cells, heart failure develops (defined as the inability of the heart to pump sufficient blood to meet the needs of the body).

In November 2019, Cardiol announced the formation of the Clinical Steering Committee (CSC) for a Phase II international trial in acute myocarditis using the CardiolRx™ CBD formulation. The CSC is expected to provide oversight of the protocol, including amendments and advice to investigators regarding all aspects of the trial.

The CSC is comprised of eight highly-distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, the University of Pittsburgh Medical Center, and Charité University Medicine Berlin.

Cardiol Steering Commuttee for covid19

Cardiol Therapeutic’s Heart Failure Program

People with heart failure suffer from a variety of ailments, including shortness of breath, rapid heart rate, edemas, reduced exercise capacity, can often struggle with simple daily activities, and are frequently hospitalized. Many of these symptoms can significantly reduce the quality of life for an individual.

There are two types of heart failure: systolic and diastolic. Systolic heart failure, or heart failure with reduced ejection fraction (HFrEF), occurs when the left ventricle cannot adequately pump blood from the heart and into circulation. Diastolic heart failure, or heart failure with preserved ejection fraction (HFpEF), occurs when the left ventricle becomes stiff and doesn’t relax as it should and, as a result, cannot fill properly, causing pressure to build in the left side of the heart and in the lungs. This results in a patient feeling shortness of breath and is associated with health concerns such as obesity, hypertension, and diabetes.

Another complication that can be experienced by those suffering from HFpEF is chronic inflammation, which can lead to a decrease in blood vessel function, impairment of heart muscle function, and fibrosis, which results in stiffness in the heart and a reduction in pumping efficiently. Over the past 20 years, there have been little to no significant treatments developed for HFpEF, as therapies have primarily remained focused on diuretics.

The Market

More than 26 million people across the globe are affected by chronic heart failure. Of this number, six million are based in Canada and the U.S., making heart failure a leading cause of death and hospitalization in the region. In the U.S. alone, the associated health costs exceed $30 billion annually.

To combat the effects of heart disease and to create a better quality of life for patients, Cardiol is developing a proprietary subcutaneous formulation of cannabidiol to achieve higher bioavailability than an oral formulation. This subcutaneous formulation would be a new approach to the treatment of chronic heart failure based on the anti-inflammatory activity of cannabidiol to treat inflamed heart tissue and the anti-fibrotic activity of cannabidiol to treat fibrosis (scarring) in heart muscle.

CardiolRx Cannabidiol Formulation

Published third-party research has shown that cannabidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cannabidiol has also been shown to attenuate a number of measures of inflammation in models of diabetes, a common co-morbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease.

Cannabidiol is lipid soluble, virtually insoluble in water, highly sensitive to deactivation in the liver via first-pass metabolism when taken orally and is rapidly cleared from the body. This results in a low overall bioavailability of less than 10% when taken orally. Cardiol’s subcutaneous administration of cannabidiol is designed to minimise first-pass metabolism, optimize and maintain blood levels of the drug, and target inflammation and increased fibrosis in the heart. Cardiol believes that overcoming the low bioavailability issues associated with cannabidiol will significantly broaden the therapeutic potential of this molecule.

 

Cardiol Therapeutic’s Strategic Partnership

Dalton Pharma Services

Cardiol has established an exclusive manufacturing arrangement with Dalton Pharma Services (Dalton) for the supply of pharmaceutical CBD for Cardiol’s research programs using CardiolRx™ and for the commercial introduction of Cortalex™.

Cardiol believes this new class of cannabidiol-based products will set new industry standards for product purity, traceability, dosimetry, and consistency while providing the Company with a significant revenue opportunity.

 

Cardiol Dalton Pharma Services

Located in Toronto, Canada, Dalton is a Health Canada approved, FDA registered, cGMP manufacturer of over 200 Active Pharmaceutical Ingredients (APIs), including pharmaceutical cannabinoids, with manufacturing capability scalable to support all stages of the regulatory process (Phase I, II, III and commercial). In 2016 and 2017, Dalton Pharma Services received the Leadership Award for Contract Manufacturing Organizations (CMO) in the following categories: Quality, Capabilities, Expertise, Compatibility and Development.

Dalton is also the manufacturer of Nabilone, the largest prescription pharmaceutical cannabinoid in the world, with annual sales of $100 million in Canada alone.

As part of the partnership, Dalton is also a significant shareholder in Cardiol. Dalton’s founder, owner and CEO, Peter Pekos, is on Cardiol’s board.

 

Cardiol Therapeutic’s Research Collaborations

DeBakey Heart and Vascular Center

Cardiol is conducting experimental research at the Houston Methodist DeBakey Heart & Vascular Center, designed to investigate the activity of the Company’s proprietary  subcutaneous cannabidiol formulation in a model of heart failure.

The Houston Methodist DeBakey Heart & Vascular Center is recognized internationally as a center of excellence for the treatment of heart failure. The center was the birthplace of cardiovascular bypass surgery in 1964 and is currently ranked the 14th best hospital for care in cardiology and heart surgery out of 5,028 hospitals in the United States.

TecSalud del Tecnológico de Monterrey

Cardiol is collaborating with TecSalud del Tecnológico de Monterrey (TecSalud) on research and development of a proprietary subcutaneous cannabidiol formulation for the treatment of heart failure. The primary objective of this collaboration is to develop the experimental evidence necessary to support advancing breakthrough treatments for heart failure into clinical development.

TecSalud has collaborative relationships with the Houston Methodist DeBakey Heart & Vascular Center and the University of Calgary and has established a formal agreement with the Massachusetts Institute of Technology (MIT) to promote research and development in nanoscience and nanotechnology in Mexico.

Cardiol Research Collaboration DeBakey Center

Cardiol Therapeutics’ Management Team

David Elsley, MBA — President, CEO and Director

Founder and CEO of Vasogen Inc., with 25 years of experience developing, financing and managing all aspects of corporate development of biotechnology and high-growth organizations.

Eldon R. Smith, OC, LLD (Hon), MD, FCAHS, FCCS, FRCPC — Chief Medical Officer and Chairman

Cardiologist; former Head of Cardiology, former Chairman of Medicine, former Dean of Medicine, University of Calgary;

Chair Steering Committee, Canadian Heart Health Strategy; recipient of Order of Canada.

Chris Waddick, MBA, CPA, CMA — Chief Financial Officer

Thirty years of experience in financial and executive roles in the biotechnology and energy industries, former Chief Financial Officer and Chief Operating Officer of Vasogen Inc.

Anne Tomalin, BA, B.Sc., RAC — Director of Regulatory Affairs

Founder of CanReg Inc and TPIreg, regulatory firms previously sold to Optum Insight and Innomar Strategies respectively. An expert in regulatory affairs in Canada, United States and Europe.

Andrea B. Parker, MSc, PhD — Director of Clinical Affairs

Chief Scientific Officer at Peter Munk Cardiac Centre, University Health Network. Clinical Epidemiologist with more than 30 years’ experience in clinical trials design, management, and execution in industry and academic settings.

Dolly Kao, BSc, JD — Intellectual Property Counsel

Co-Founder of PCK LLP. Highly experienced IP lawyer with a practice focused primarily on patent and trademark matters (procurement, oppositions, and opinions) for clients in the chemical, pharmaceutical, and biotechnology industries.

Thomas Moffat, BBA – Chief Commercial Officer

Senior operations and retailing executive with an extensive background in the pharmaceutical environment; more than 20 years’ tenure at Shoppers Drug Mart.

Anthony E. Bolton, B.Sc., Ph.D., D.Sc. — Director of Research

Immunologist, 20+ years of experience in biotechnology, Chief Scientific Officer of Vasogen Inc.; former Professor and Department Head of Biomedical Sciences, Sheffield, UK.

Blagoja Ristevski, B.Sc., CHE — Director of Chemical Engineering and Manufacturing

Chemical Engineer, 25+ years of experience in the biopharmaceutical industry, senior exec. roles in eight Canadian biopharmaceutical Co.’s in the research/discovery of drug products; VP Product Dev., AMRIC Institute, Ontario, Canada.

Guillermo Torre-Amione, MD, Ph.D. — Director

President of TecSalud academic medical center and school of the Instituto Tecnológico y de Estudios Superiores de Monterrey (ITESM), Mexico. Former director of Cardiac Transplantation at the Houston Methodist DeBakey Heart & Vascular Center.

Peter Pekos, B.Sc., M.Sc. — Director

President, CEO and Founder at Dalton Pharma Services with broad experience in the research, development and commercialization of pharmaceuticals, products and services.

Deborah Brown, MBA — Director

Partner at Accelera Canada with multiple years advising pharmaceutical clients in strategy and initiatives, market research, market access and regulatory affairs. Previously President, EMD Serono Canada (division of Merck KGaA, Merck Serono).

Iain Chalmers, BA, BEd, MBA — Director

Professor of Marketing at Centennial College Business School. Former Vice-President Marketing and Innovation at Diageo, the world’s largest spirits company. Over 25 years’ experience in consumer products with Gillette and Procter & Gamble.

Colin Stott — Director

Thirty years of experience in pre-clinical and clinical development, with specific expertise in the development of cannabinoid-based medicines. Currently Chief Operating Officer of Alinova Biosciences Ltd. and former Scientific Affairs Director, International and R&D Operations Director for GW Pharmaceuticals plc, a world leader in the development of cannabinoid therapeutics.

Michael J. Willner, Esq. — Business Advisor

Mr. Willner has been an active investor for over forty years and is the founder of Willner Capital, Inc., an investment company specializing in both public and private equities. Over the past several years, Willner Capital has made significant investments in both the biotechnology and medicinal cannabinoid industries, focusing primarily on clinical-stage companies that seek to address significant unmet medical needs. Mr. Willner has served on numerous panels and advisory boards and as a judge in the medicinal cannabinoid industry start-up competitions and conferences. He has been quoted in the New York Times regarding his investments and is considered an expert in the medicinal/pharmaceutical cannabinoids industry.

Mr. Willner currently serves on the advisory boards of CannaVC, a cannabis-focused venture capital fund for the Israeli market, managed by the Everest Group, which plans to invest in companies that have developed an innovative solution/service/product for the cannabinoid sector, and CURE Pharmaceutical® (OTCQB:CURR), a vertically integrated drug delivery and development company that partners with biotech and pharmaceutical companies worldwide.

Steven Grasso — Business Advisor

Mr. Grasso began his career on the floor of the New York Stock Exchange in 1993. He joined Stuart Frankel & Co. as an institutional sales trader in 1999. As Director of Institutional Sales for Stuart Frankel & Co., Steven has worked closely with some of the largest mutual funds, pension funds, insurance companies, and hedge funds in the world directly from the floor of the Stock Exchange. Over his 27-year career, Steven has actively participated in various Stock Exchange committees ranging from allocating new listings to designated market makers to developing standardized tests that the floor community uses for continuing education. Steven closely follows the Washington D.C./Markets connection, using his extensive Capitol Hill and SEC relationships to better inform his clients on policy changes and regulation.

Steven is perhaps best known for being a CNBC market analyst and is a regular on CNBC’s popular “Fast Money” show, which airs daily during the business week and has an average daily viewership that currently exceeds 250,000. Mr. Grasso also speaks at many traders’ conferences across the country on a regular basis, as well as business round tables with many influential leaders of industry where he addresses a broad range of market related issues, including the effects of regulation and the political process on equities.


 

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